EUCTR2012-004088-38-SE进行中（未招募）不适用
Pilot study to downregulate allergic responses in adults with allergic rhinoconjunctivitis by using three intralymphatic injections of grass or birch allergen one month in between during the non-seasonal period. - Pilot-ILIT (Pilot trial to down regulate allergy by IntraLymphatic allergen ImmunoTherapy
Allergy Centre, University Hospital0 个研究点开始时间: 2012年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age 18-50 years,
- •Seasonal allergic symptoms for grass or birch verified by skin prick test.
- •Accepted and signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The presence of any of the following will exclude the potential study
- •patient from entry into the study:
- •Pregnancy or nursing, or planning for that. Women with childbearing
- •potential should use contraceptives. Condom only is not enough as
- •contraceptive.
- •Autoimmune or collagen disease
- •Grave cardiovascular disease, milder cases decided by the investigator
- •Perennial pulmonary disease, FEV1 < 80 % of predicted, or use of more
- •then 400 microgram budesonide (or equivalent/day)
- •Recent or on-going hepatic disease
- •Recent or on-going renal disease
- •Cancer – as decided by the investigator
- •Any medication with a possible side effect of interfering with the
- •immune response, Previous immuno- or chemotherapy
- •Upper airway disease (non-allergic sinusitis, nasal polyps)
- •Chronic obstructive and restrictive lung disease
- •Disease or conditions rendering the treatment of anaphylactic reactions
- •difficult (symptomatic coronary heart diseases, severe arterial
- •hypertension and treatment with Beta-blockers)
- •Major metabolic disease
- •Known or suspected allergy for addatives in the study product
- •Alcohol or drug abuse
- •Mental incapability of coping with the study
- •Participation in another clinical study within 30 days that could jeopardize this study
研究者
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